The beneficial effect of Batroxobin on blood loss reduction in spinal fusion surgery

a prospective, randomized, double-blind, placebo-controlled study

Hui-Min Hu, Li Chen, Charles Frary, Chi-Chih Chang, Hua Hui, Hai-Ping Zhang, Da-Geng Huang, Zhong-Kai LiuLiu, Yuan-Ting Zhao, Si-Min He, Xue-Fang Zhang, Bao-Rong He, Ding-Jun Hao

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

Objective Our objective was to evaluate the efficacy and safety of Batroxobin on blood loss during spinal operations. Methods After obtaining approval from the ethics committee at the hospital along with informed written consent, we performed a double-blind, randomized, placebo-controlled study with 100 patients who were randomized equally into 2 groups (Batroxobin and placebo). Patients received either 2 ku IV 15 min before surgery and followed 1 ku IM of Batroxobin following surgery, or an equivalent volume of placebo (normal saline). Cost of Batroxobin treatment is amounted to 84.75 euros. The primary outcomes were intraoperative, 24 h postoperative, and total perioperative blood loss. Secondary outcomes were hemoglobin (Hb), red blood cell count (RBC), the volume of blood/fluid transfusion intraoperatively, and 24 h postoperatively. Safety evaluation parameters were the incidence of venous thrombosis in the lower extremities, active partial thromboplastin time, prothrombin time, thrombin time, and fibrinogen. The data were analyzed using the Statistical Package for the Social Science Version 12.0. The results were presented as mean ± SEM. The Mann–Whitney test and Independent Student t test, when appropriate, were used to compare the 2 groups, and differences were considered significant if the P value was <0.05. Results 88 patients were included in the analysis while 12 patients were withdrawn from the study due to extended surgical duration, change of surgical procedure, or after the patients’ request. The total perioperative blood loss was approximately 31 % lower in patients given Batroxobin versus placebo (700.5 ± 45.81 vs 485.7 ± 30.01 mL, P = 0.001). The Batroxobin group had significantly less intraoperative blood loss (326.1 ± 24.16) compared to the placebo group (556.0 ± 43.58), but there was no difference in the amount of blood/fluid transfused, postoperatively Hb, or RBC between the two groups. After the operation, coagulation parameters were not significantly different between the 2 groups at the days 1 or 3 postoperatively. No adverse events related to the use of Batroxobin were recorded. There were no cases of superficial wound infection. None of the subjects died during the study. Conclusions In this study, prophylactic use of Batroxobin provided an effective and cheap method for reducing blood loss without coagulopathy during or after operations. The use of Batroxobin for patients undergoing one-level PLIF surgery safely and effectively reduced the total amount of perioperative blood loss
OriginalsprogEngelsk
TidsskriftArchives of Orthopaedic and Trauma Surgery
Vol/bind135
Udgave nummer4
Sider (fra-til)491-497
ISSN0936-8051
DOI
StatusUdgivet - 27. feb. 2015

Fingeraftryk

Batroxobin
Placebos
Clinical Ethics Committees
Safety
Partial Thromboplastin Time
Prothrombin Time
Informed Consent
Cell Size

Citer dette

Hu, Hui-Min ; Chen, Li ; Frary, Charles ; Chang, Chi-Chih ; Hui, Hua ; Zhang, Hai-Ping ; Huang, Da-Geng ; LiuLiu, Zhong-Kai ; Zhao, Yuan-Ting ; He, Si-Min ; Zhang, Xue-Fang ; He, Bao-Rong ; Hao , Ding-Jun . / The beneficial effect of Batroxobin on blood loss reduction in spinal fusion surgery : a prospective, randomized, double-blind, placebo-controlled study. I: Archives of Orthopaedic and Trauma Surgery. 2015 ; Bind 135, Nr. 4. s. 491-497.
@article{91405a4ffc5a4cb38b9d1eba05a668d8,
title = "The beneficial effect of Batroxobin on blood loss reduction in spinal fusion surgery: a prospective, randomized, double-blind, placebo-controlled study",
abstract = "Objective Our objective was to evaluate the efficacy and safety of Batroxobin on blood loss during spinal operations. Methods After obtaining approval from the ethics committee at the hospital along with informed written consent, we performed a double-blind, randomized, placebo-controlled study with 100 patients who were randomized equally into 2 groups (Batroxobin and placebo). Patients received either 2 ku IV 15 min before surgery and followed 1 ku IM of Batroxobin following surgery, or an equivalent volume of placebo (normal saline). Cost of Batroxobin treatment is amounted to 84.75 euros. The primary outcomes were intraoperative, 24 h postoperative, and total perioperative blood loss. Secondary outcomes were hemoglobin (Hb), red blood cell count (RBC), the volume of blood/fluid transfusion intraoperatively, and 24 h postoperatively. Safety evaluation parameters were the incidence of venous thrombosis in the lower extremities, active partial thromboplastin time, prothrombin time, thrombin time, and fibrinogen. The data were analyzed using the Statistical Package for the Social Science Version 12.0. The results were presented as mean ± SEM. The Mann–Whitney test and Independent Student t test, when appropriate, were used to compare the 2 groups, and differences were considered significant if the P value was <0.05. Results 88 patients were included in the analysis while 12 patients were withdrawn from the study due to extended surgical duration, change of surgical procedure, or after the patients’ request. The total perioperative blood loss was approximately 31 {\%} lower in patients given Batroxobin versus placebo (700.5 ± 45.81 vs 485.7 ± 30.01 mL, P = 0.001). The Batroxobin group had significantly less intraoperative blood loss (326.1 ± 24.16) compared to the placebo group (556.0 ± 43.58), but there was no difference in the amount of blood/fluid transfused, postoperatively Hb, or RBC between the two groups. After the operation, coagulation parameters were not significantly different between the 2 groups at the days 1 or 3 postoperatively. No adverse events related to the use of Batroxobin were recorded. There were no cases of superficial wound infection. None of the subjects died during the study. Conclusions In this study, prophylactic use of Batroxobin provided an effective and cheap method for reducing blood loss without coagulopathy during or after operations. The use of Batroxobin for patients undergoing one-level PLIF surgery safely and effectively reduced the total amount of perioperative blood loss",
author = "Hui-Min Hu and Li Chen and Charles Frary and Chi-Chih Chang and Hua Hui and Hai-Ping Zhang and Da-Geng Huang and Zhong-Kai LiuLiu and Yuan-Ting Zhao and Si-Min He and Xue-Fang Zhang and Bao-Rong He and Ding-Jun Hao",
year = "2015",
month = "2",
day = "27",
doi = "10.1007/s00402-015-2183-0",
language = "English",
volume = "135",
pages = "491--497",
journal = "Archives of Orthopaedic and Trauma Surgery",
issn = "0936-8051",
publisher = "Heinemann",
number = "4",

}

Hu, H-M, Chen, L, Frary, C, Chang, C-C, Hui, H, Zhang, H-P, Huang, D-G, LiuLiu, Z-K, Zhao, Y-T, He, S-M, Zhang, X-F, He, B-R & Hao , D-J 2015, 'The beneficial effect of Batroxobin on blood loss reduction in spinal fusion surgery: a prospective, randomized, double-blind, placebo-controlled study', Archives of Orthopaedic and Trauma Surgery, bind 135, nr. 4, s. 491-497. https://doi.org/10.1007/s00402-015-2183-0

The beneficial effect of Batroxobin on blood loss reduction in spinal fusion surgery : a prospective, randomized, double-blind, placebo-controlled study. / Hu, Hui-Min; Chen, Li; Frary, Charles; Chang, Chi-Chih ; Hui, Hua ; Zhang, Hai-Ping; Huang, Da-Geng; LiuLiu, Zhong-Kai ; Zhao, Yuan-Ting ; He, Si-Min ; Zhang, Xue-Fang ; He, Bao-Rong; Hao , Ding-Jun .

I: Archives of Orthopaedic and Trauma Surgery, Bind 135, Nr. 4, 27.02.2015, s. 491-497.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - The beneficial effect of Batroxobin on blood loss reduction in spinal fusion surgery

T2 - a prospective, randomized, double-blind, placebo-controlled study

AU - Hu, Hui-Min

AU - Chen, Li

AU - Frary, Charles

AU - Chang, Chi-Chih

AU - Hui, Hua

AU - Zhang, Hai-Ping

AU - Huang, Da-Geng

AU - LiuLiu, Zhong-Kai

AU - Zhao, Yuan-Ting

AU - He, Si-Min

AU - Zhang, Xue-Fang

AU - He, Bao-Rong

AU - Hao , Ding-Jun

PY - 2015/2/27

Y1 - 2015/2/27

N2 - Objective Our objective was to evaluate the efficacy and safety of Batroxobin on blood loss during spinal operations. Methods After obtaining approval from the ethics committee at the hospital along with informed written consent, we performed a double-blind, randomized, placebo-controlled study with 100 patients who were randomized equally into 2 groups (Batroxobin and placebo). Patients received either 2 ku IV 15 min before surgery and followed 1 ku IM of Batroxobin following surgery, or an equivalent volume of placebo (normal saline). Cost of Batroxobin treatment is amounted to 84.75 euros. The primary outcomes were intraoperative, 24 h postoperative, and total perioperative blood loss. Secondary outcomes were hemoglobin (Hb), red blood cell count (RBC), the volume of blood/fluid transfusion intraoperatively, and 24 h postoperatively. Safety evaluation parameters were the incidence of venous thrombosis in the lower extremities, active partial thromboplastin time, prothrombin time, thrombin time, and fibrinogen. The data were analyzed using the Statistical Package for the Social Science Version 12.0. The results were presented as mean ± SEM. The Mann–Whitney test and Independent Student t test, when appropriate, were used to compare the 2 groups, and differences were considered significant if the P value was <0.05. Results 88 patients were included in the analysis while 12 patients were withdrawn from the study due to extended surgical duration, change of surgical procedure, or after the patients’ request. The total perioperative blood loss was approximately 31 % lower in patients given Batroxobin versus placebo (700.5 ± 45.81 vs 485.7 ± 30.01 mL, P = 0.001). The Batroxobin group had significantly less intraoperative blood loss (326.1 ± 24.16) compared to the placebo group (556.0 ± 43.58), but there was no difference in the amount of blood/fluid transfused, postoperatively Hb, or RBC between the two groups. After the operation, coagulation parameters were not significantly different between the 2 groups at the days 1 or 3 postoperatively. No adverse events related to the use of Batroxobin were recorded. There were no cases of superficial wound infection. None of the subjects died during the study. Conclusions In this study, prophylactic use of Batroxobin provided an effective and cheap method for reducing blood loss without coagulopathy during or after operations. The use of Batroxobin for patients undergoing one-level PLIF surgery safely and effectively reduced the total amount of perioperative blood loss

AB - Objective Our objective was to evaluate the efficacy and safety of Batroxobin on blood loss during spinal operations. Methods After obtaining approval from the ethics committee at the hospital along with informed written consent, we performed a double-blind, randomized, placebo-controlled study with 100 patients who were randomized equally into 2 groups (Batroxobin and placebo). Patients received either 2 ku IV 15 min before surgery and followed 1 ku IM of Batroxobin following surgery, or an equivalent volume of placebo (normal saline). Cost of Batroxobin treatment is amounted to 84.75 euros. The primary outcomes were intraoperative, 24 h postoperative, and total perioperative blood loss. Secondary outcomes were hemoglobin (Hb), red blood cell count (RBC), the volume of blood/fluid transfusion intraoperatively, and 24 h postoperatively. Safety evaluation parameters were the incidence of venous thrombosis in the lower extremities, active partial thromboplastin time, prothrombin time, thrombin time, and fibrinogen. The data were analyzed using the Statistical Package for the Social Science Version 12.0. The results were presented as mean ± SEM. The Mann–Whitney test and Independent Student t test, when appropriate, were used to compare the 2 groups, and differences were considered significant if the P value was <0.05. Results 88 patients were included in the analysis while 12 patients were withdrawn from the study due to extended surgical duration, change of surgical procedure, or after the patients’ request. The total perioperative blood loss was approximately 31 % lower in patients given Batroxobin versus placebo (700.5 ± 45.81 vs 485.7 ± 30.01 mL, P = 0.001). The Batroxobin group had significantly less intraoperative blood loss (326.1 ± 24.16) compared to the placebo group (556.0 ± 43.58), but there was no difference in the amount of blood/fluid transfused, postoperatively Hb, or RBC between the two groups. After the operation, coagulation parameters were not significantly different between the 2 groups at the days 1 or 3 postoperatively. No adverse events related to the use of Batroxobin were recorded. There were no cases of superficial wound infection. None of the subjects died during the study. Conclusions In this study, prophylactic use of Batroxobin provided an effective and cheap method for reducing blood loss without coagulopathy during or after operations. The use of Batroxobin for patients undergoing one-level PLIF surgery safely and effectively reduced the total amount of perioperative blood loss

U2 - 10.1007/s00402-015-2183-0

DO - 10.1007/s00402-015-2183-0

M3 - Journal article

VL - 135

SP - 491

EP - 497

JO - Archives of Orthopaedic and Trauma Surgery

JF - Archives of Orthopaedic and Trauma Surgery

SN - 0936-8051

IS - 4

ER -