Low Molecular Weight Heparin (KABI2165) as Thromboprophylaxis in Elective Visceral Surgery

Q: What are the key findings of this study?

Low-dose LMW heparin (KABI2165, 2,500 IU/day) had equal thromboembolic events (2.86% vs 2.94%) and bleeding (14.9% vs 15.3%) vs UF heparin after 7,500 IU caused excess bleeding (47.8% vs 10%, p<0.01).

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Elective visceral surgery requiring perioperative thromboprophylaxis (n=189). Intervention: Low molecular weight heparin fragment (KABI2165) vs. Unfractionated heparin (2 x 5,000 IU daily). Primary outcome: Thromboembolic events (Study 2; perioperative bleeding complications also co-assessed at 14.9% vs 15.3%).

Q: What does this research mean for the field?

A once-daily low dose of LMW heparin (2,500 anti-factor Xa IU/day) provides equivalent thromboprophylactic efficacy and bleeding risk compared to twice-daily unfractionated heparin in elective visceral surgery, whereas a higher dose (7,500 IU/day) causes excessive bleeding. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.NEUTRAL.

Matthias Köller; U Schoch; P Buchmann; F Largiadèr; A. von Felten; P Frick

doi:10.1055/s-0038-1661658

January 1, 1986Thrombosis and Haemostasis

Low Molecular Weight Heparin (KABI2165) as Thromboprophylaxis in Elective Visceral Surgery

View at Publisher

Ask AI

Bookmark

Share

Key result

Low-dose LMW heparin matches unfractionated heparin for thromboembolic and bleeding events after initial high-dose safety stop.

n=189

Key Points

To assess perioperative bleeding complications and thromboembolic events comparing low molecular weight heparin fragment KABI 2165 with unfractionated heparin in elective visceral surgery.
Two randomized double-blind trials conducted in 189 patients undergoing elective visceral surgery receiving subcutaneous heparin regimens.
The initial trial evaluated once-daily LMW heparin (7,500 anti-factor Xa IU) against twice-daily unfractionated heparin (5,000 IU).
A subsequent trial evaluated a reduced dose of once-daily LMW heparin (2,500 anti-factor Xa IU / 15 mg) versus unfractionated heparin in 146 patients.
The first trial was terminated early due to excessive bleeding complications with high-dose LMW heparin (11/23 patients vs. 2/20 patients with unfractionated heparin, p < 0.01).
In the second trial, bleeding complications were 14.9% with reduced-dose LMW heparin versus 15.3% with unfractionated heparin.
Thromboembolic event rates were 2.86% in the LMW heparin arm and 2.94% in the unfractionated heparin arm.

Study Design

Type

RCT (n=189)

Blinding

Double-blind

Randomization

Randomized

PICO

P

Population

189 patients undergoing elective visceral surgery across two randomized double-blind studies (43 in study 1, 146 in study 2).

I

Intervention / Comparator

Low molecular weight heparin fragment (KABI2165) vs Unfractionated heparin (2 x 5,000 IU daily) (1 x 2,500 anti-factor Xa IU (15 mg) daily (study 2); 1 x 7,500 anti-factor Xa IU daily (study 1, interrupted))

O

Primary Outcome

Thromboembolic events (Study 2; perioperative bleeding complications also co-assessed at 14.9% vs 15.3%)

Main Result

Absolute Event Rate: 2.86% vs 2.94%

Limitations

The first study comparing 7,500 anti-factor Xa IU LMW heparin daily with UF heparin was interrupted early due to excessive bleeding complications.

Ask about this paper

Answers are grounded in this paper and cite their sources.

Implication

Randomized double-blind trial demonstrates low-dose low molecular weight heparin matches unfractionated heparin safety in visceral surgery, indicating effective once-daily prophylaxis.

Abstract

In two randomized double-blind studies perioperative bleeding complications and thromboembolic events were assessed in 189 patients (pts) undergoing elective visceral surgery after subcutaneous administration of a low molecular weight (LMW) heparin fragment (KABI fragment 2165) or unfractionated (UF) heparin. The first study comparing 1 X 7'500 anti-factor Xa IU LMW heparin daily with 2 X 5'000 IU UF heparin was interrupted because of excessive bleeding complications (LMW heparin: 11/23 pts, UF heparin: 2/20 pts, p less than 0.01). In the second study (146 pts) the dose of LMW heparin was reduced to 1 X 2'500 anti-factor Xa IU. Bleeding complications (LMW heparin: 14.9%, UF heparin: 15.3%) and thromboembolic events (LMW heparin: 2.86%, UF heparin: 2.94%) were equal among the two groups. 2'500 anti-factor Xa IU/day of this LMW heparin fragment, corresponding to 15 mg/day, is the lowest dose of a LMW heparin used in a randomized clinical trial and was found to be a safe and efficient regimen in perioperative thrombosis prophylaxis. An advantage of LMW heparin over UF heparin is its once daily administration.

Discussion

No takes yet. Share an insight, caveat, or question.

Cite This Study

Köller et al. (1986) conducted an RCT in Elective visceral surgery requiring perioperative thromboprophylaxis (n=189). Low molecular weight heparin fragment (KABI2165) vs. Unfractionated heparin (2 x 5,000 IU daily) was evaluated on Thromboembolic events (Study 2; perioperative bleeding complications also co-assessed at 14.9% vs 15.3%). Low-dose LMW heparin (KABI2165, 2,500 IU/day) had equal thromboembolic events (2.86% vs 2.94%) and bleeding (14.9% vs 15.3%) vs UF heparin after 7,500 IU caused excess bleeding (47.8% vs 10%, p<0.01).

synapsesocial.com/papers/6a72906bce524a4339c57cba https://doi.org/10.1055/s-0038-1661658

View at Publisher

Ask AI

Bookmark

Share

Low Molecular Weight Heparin (KABI2165) as Thromboprophylaxis in Elective Visceral Surgery

Key Points

Study Design

PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Low Molecular Weight Heparin (KABI2165) as Thromboprophylaxis in Elective Visceral Surgery

Key Points

Study Design

PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Keep reading

Keep reading